Evacetrapib’s ACCELERATE trial highlights the need for high-quality Phase III cardiovascular outcomes trials (CVOTs) prior to approvals.
By Louisa Joseph, Analyst
10 April 2016
ACCELERATE investigators presented full data from the trial at the American College of Cardiology’s 65th Annual Scientific Session, demonstrating the stark disconnect between evacetrapib’s positive effect on lipid parameters and lack of impact on CV outcomes. Whilst evacetrapib was shown to raise HDL-C levels by 130% and reduce LDL-C by 37%, it’s the clinical impact on CV outcomes that counts, and no benefit was seen. The composite primary endpoint of major CV events including heart attack, stroke, angina or CV death was virtually identical in the evacetrapib and placebo groups over the three year study.
These findings clearly demonstrate the limitations of using cholesterol biomarkers as a surrogate for CV benefit as positive movements in these levels often don’t translate into improvements in CV outcomes. With one CETP inhibitor candidate still in the running, skepticism surrounding anacetrapib’s (Merck & co) ability to reduce CV risk is growing. Anacetrapib is currently in a Phase III CVOT known as REVEAL, which is expected to finish in Q1 2017 (ClinicalTrials.gov identifier: NCT01252953). Demonstrating a clear improvement in CV outcomes in this ongoing trial will be vital for anacetrapib to gain approval in the dyslipidemia market, however this seems less and less likely.
|First event of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization
|Mean HDL-C at 30 months
|46 mg/dL||104 mg/dL (P<0.001)|
|Mean LDL-C at 30 months
The above is excerpted from Datamonitor Healthcare’s Dyslipidemia: content, which includes a detailed look at the current treatment algorithms and prescribing trends, the impact of newly branded therapies on the Dyslipidemia market, and insight into the current Dyslipidemia pipeline.
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